SpyScope Access and Delivery Catheter
by Boston Scientific 510(k)
Active
510(k) K090170
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090170 | Date4 Feb 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ODF
- FDA applicant
- Boston Scientific Corp
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SpyScope Access and Delivery Catheter is a Mini Endoscope (per FDA nomenclature) designed for diagnostic and therapeutic procedures in gastroenterology and urology. It enables direct visualization of biliary and pancreatic ducts, as well as complex strictures and stones, via an integrated imaging system. Its primary function is to facilitate real-time assessment and intervention during endoscopic retrograde cholangiopancreatography (ERCP) and related procedures.
This catheter is supplied as a single-use, non-sterile device (as indicated by the FDA 510(k) clearance) and is intended for use in controlled clinical settings. It is compatible with diagnostic and therapeutic accessories, including those for stone management and tissue inspection. The device is classified under FDA regulation 876.1500 and falls under Class II medical devices. Storage and handling must adhere to manufacturer guidelines to ensure proper functionality and sterility before use.
Other devices from Boston Scientific
Questions
AI-generated answers, 19 Sep 2026
Is the SpyScope Access and Delivery Catheter intended for reuse, or is it designed for single-use only?
The SpyScope Access and Delivery Catheter is explicitly supplied as a single-use device, as confirmed by the FDA’s 510(k) clearance. This means it is not meant to be reused after a single procedure, and proper disposal after use is required to maintain safety and sterility standards.
What types of procedures is this catheter primarily used for, and how does it improve visualization during those procedures?
This catheter is designed for diagnostic and therapeutic procedures in gastroenterology and urology, particularly during ERCP (endoscopic retrograde cholangiopancreatography). It integrates an imaging system to provide real-time visualization of biliary and pancreatic ducts, complex strictures, and stones, enabling precise assessment and intervention without relying solely on fluoroscopy.
How should the SpyScope Access and Delivery Catheter be stored before use, and is it sterile as shipped?
The device is non-sterile as shipped and must be sterilized by the manufacturer before use, as indicated in the FDA clearance. Storage and handling must follow the manufacturer’s guidelines to ensure proper functionality and sterility prior to clinical use, typically involving terminal sterilization processes.
What regulatory pathway was followed for FDA clearance, and what class does this device fall under?
The SpyScope Access and Delivery Catheter received FDA 510(k) clearance through a traditional review pathway, determined to be substantially equivalent to a predicate device. It is classified under FDA regulation 876.1500 and falls within Class II medical devices, indicating moderate regulatory oversight.